Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Summary

This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor \[CAR\] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory AML.

Conditions

• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia

Interventions

DRUG

Autologous Anti-CD83 CAR T-cells

Given IV

PROCEDURE

Biospecimen Collection

Undergo bone marrow aspiration blood sample collection

PROCEDURE

Chest Radiography

Undergo chest x-ray

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine Phosphate

Given IV

DRUG

Hydroxyurea

Given hydroxyurea

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Positron Emission Tomography

Undergo PET

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Shernan G Holtan · Roswell Park Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-02

Primary Completion

2028-04-01

Completion

2028-04-01

FDA Drug

Yes

Countries

• United States

Study Locations